A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

Inclusion Criteria

• •The screening window for this trial is 45 days.
• •To be eligible for study entry, patients must satisfy all of the following criteria:
• •Adult patients 50 years to ≤ 85 years of age at the time of consent;
• •Meets the diagnostic criteria of MCI of probable Alzheimer's disease (Jack et al. 2018; NIA-AA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018). (NIA-AA);
• •Amyloid positive (documented in medical history or assessed during screening through blood test);
• •Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others;
• •Residence in an assisted living is allowed as is personal assistances provided in the home, however at time of enrollment participant must be able to perform most ADL with minimal assistance, and participant must be permitted sufficient independence to allow assessment of change in ADL;
• •Has a study partner for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which caregiver assessments are performed.